Gut MicrobiomeNCT07839156
Tiny Tummies - A Milk Study
A study testing Daily cow's milk products and Daily Oat Milk Exposure in people with Gut Microbiome and Neurocognitive Correlates of Eating Habits, run by Arizona State University at 1 site in United States.
Trial summary
This is a 12-month, 2-arm randomized controlled trial (n=150) examining whether toddlers randomized at 12 months of age to 1.5 cup-equivalents/day of cow's milk-based dairy versus oat milk-based dairy, and followed to 24 months, have better growth, sleep, neurocognitive, and gut microbiome outcomes. Read more about this study
- Who is it for?
- Ages 6 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiome, Neurocognitive Correlates of Eating Habits, Infants and Young Children
- What is being tested?
- Daily cow's milk products and Daily Oat Milk Exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2026to 30 Jan 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children born to mothers 18 years and older while pregnant
- Parents speak English and/or Spanish
- At least one caregiver in the home must have at least an 8th-grade education level
- Children still being breastfed into toddlerhood will be eligible to participate. Breastfeeding frequency and duration will be tracked in this case for statistical model adjustment.
Who cannot join
- Children regularly taking probiotics and/or antibiotics (e.g., due to chronic ear infections)
- Children with known allergies to cow's milk or oat products
- Children introduced to fluid cow's or oat milk prior to 12 months of age however, yogurt and cheese made from cow's or oat milk will be acceptable and will be quantified for model adjustment during statistical analyses
- Children born with growth, chromosomal, or genetic abnormality, developmental and cognitive impairments, or severe comorbidity that could impact growth and development
- Children born with congenital abnormalities or developmental delays
- Children born with birth weights <2500 g or >4000 g
Show all 10Show fewer
- Biological mothers must have no known substance use during the child's pregnancy (alcohol, tobacco, marijuana, or illegal drugs)
- Biological mothers who experienced a high-risk pregnancy (e.g., preeclampsia, diabetes-Types 1 and 2 and gestational, HIV, etc.) that affected child growth
- A family history of dairy or gluten (oats are sometimes contaminated with gluten) allergies will be evaluated to assess the child's risk. If either the child's mother or father is allergic to dairy and/or gluten, physician clearance for child participation will be needed
- The toddler's biological parents have heritable diseases that could influence the findings (e.g., autism).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Beyond the Bottle: Investigating the Differential Biological Effects of Cow's Milk and Oat Milk on Toddler Development
This is a 12-month, 2-arm randomized controlled trial (n=150) examining whether toddlers randomized at 12 months of age to 1.5 cup-equivalents/day of cow's milk-based dairy versus oat milk-based dairy, and followed to 24 months, have better growth, sleep, neurocognitive, and gut microbiome outcomes.
- Conditions
- Gut Microbiome, Neurocognitive Correlates of Eating Habits, Infants and Young Children, Sleep
- Being tested
- Daily cow's milk products, Daily Oat Milk Exposure
- Keywords
- milk, oatmilk, toddlers, growth, development, gut microbiome, neurocognitive, brain health, sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily cow's milk productsOther
Toddlers in the cow's milk group will receive 1.5 cup equivalents per day of cow-based dairy (1 cup of fluid milk + ½ cup equivalent of cheese (0.75 oz.) or yogurt (1/2 cup)).
Daily Oat Milk ExposureOther
Toddlers in the oat milk group will receive 1.5 cup equivalents per day of oat milk (1 cup of fluid milk + ½ cup equivalent of cheese (0.75 oz.) or yogurt (1/2 cup)).
| Study group | Role | What they receive |
|---|---|---|
| Cow's Milk | Experimental | Toddlers in the cow's milk group will receive 1.5 cup equivalents per day of cow-based dairy (1 cup of fluid milk + ½ cup equivalent of cheese (0.75 oz.) or yogurt (1/2 cup)). Receives: Other: Daily cow's milk products |
| Oat Milk | Active comparator | Toddlers in the oat milk group will receive 1.5 cup equivalents per day of oat milk (1 cup fluid oat milk) + ½ cup equivalent of oat-based cheese (0.75 oz.) or yogurt (1/2 cup)). Receives: Other: Daily Oat Milk Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut Microbiome Diversity
Microbial DNA extracted from toddler stool samples will undergo shotgun metagenomic sequencing to identify the unique species present in the gut microbial community and evaluate the richness and abundance of microbes present in the stool.
Measured: At enrollment to the end of treatment at 12 months
Toddler length
Toddler length will be assessed with a pediatric length board and reported in centimeters.
Measured: From enrollment to the end of treatment at 12 months
Toddler weight
Infant weight will be assessed with a calibrated scale and reported in grams.
Measured: From enrollment to the end of treatment at 12 months
Vineland Adaptive Behavior Scale (Vinland-3)
A questionnaire completed by the parent/caregiver that is normed for ages from birth through 90 years. The tool assesses adaptive behaviors (things people do to function in everyday life) in three domains: communication, daily living skills, and socialization.
Measured: From enrollment to the end of treatment at 12 months
McArthur Bates Communicative Development Inventories III (MBCDI-III)
A widely used checklist completed by parents to assess children's early communication skills such as comprehension and use of gestures and words.
Measured: From enrollment to the end of treatment at 12 months
Mullen Scales of Early Learning
Study staff will administer a structured 15-minute play session with the infant to objectively assess motor, visual, and early language skills.
Measured: From enrollment to the end of treatment at 12 months
Brief Infant Sleep Questionnaire - Extended
Sleep location, duration, quality, and interactions; validated for infants and toddlers through age 3 years; REDCap online. Scores range from 0-100 with higher scores representing healthier, more consolidated sleep patterns (e.g., shorter time to fall asleep, fewer and shorter night wakings).
Measured: From enrollment to the end of treatment at 12 months
Sleep-Wake Patterns measured by actigraphy (time awake and asleep)
Actigraphy is a standard, valid, noninvasive measure for assessing sleep and circadian rhythm patterns across the life course. For infants and young children (e.g., toddlers), the actigraph is a small watch-like device that will be worn around the left ankle to record body motion (activity counts). The child will wear the devices for 7 continuous days and nights after all in-home visits. Constant assessment is necessary to capture the full development of sleep-wake patterns and circadian rhythmicity across toddlerhood. Home visits will be scheduled to avoid current illnesses or well-visits to avoid vaccination effects on sleep patterns. Primary sleep variables will be averaged across the recording period. Data will be reported in minutes of time that the child is awake or asleep.
Measured: From enrollment to the end of treatment at 12 months
Parent-Reported Sleep-Wake Patterns (time awake and asleep, and number of naps and perceived quality of sleep episodes)
During actigraphy data collection, the parent/guardian will complete sleep diaries on the sleep of their toddler. Diaries will be used to identify artifacts that might affect motion (externally induced motion e.g. car seat, swing, or constricted motion e.g. swaddling), and to define sleep periods from actigraphy outputs for children prior to analysis with the sleep-wake algorithms. Primary sleep diary variables will be (1) bed/nap clock times attempted to sleep, (2) bed/nap clock times of sleep bout awakenings, and (3) time in bed or interval between attempted bed and wake times.
Measured: From enrollment to the end of treatment at 12 months
Home Observation for Measurement of the Environment Inventory (quality and extent of stimulation, support, and learning resources in the home)
Research personnel will objectively evaluate the caring environment in which a child is raised and parent-child interaction using this validated assessment. The inventory qualitatively assesses the quality and extent of stimulation, support, and learning resources available in a child's home environment.
Measured: From enrollment to the end of treatment at 12 months
Secondary outcomes (5)
Infant 24-hour Diet Records
Habitual intake will be assessed via the Automated Self-Administered 24-hr recall software (ASA24) on 2 weekdays and one weekend day developed by the National Cancer Institute.
Measured: From enrollment to the end of treatment at 12 months
Food intake photos showing the infant consuming intervention foods (compliance measure)
Pre-post meal photos of the infant and their food will be provided by the parents. These images will be used to help corroborate dietary intake and behavior data.
Measured: From enrollment to the end of treatment at 12 months
Centers for Disease Control Infant Feeding Questionnaire to assess feeding practices in toddlerhood
This questionnaire asks about breastfeeding, formula feeding, complementary feeding, introduction to solid foods, food allergies, and participation in the Special Supplemental Nutrition Assistance Program for Women, Infant, and Children.
Measured: From enrollment to the end of treatment at 12 months
Food Security Screener
The USDA 6-Item Food Security Screener will be used to assess household food insecurity. Scores range from 0-6 with higher scores representing higher levels of food insecurity.
Measured: From enrollment to the end of treatment at 12 months
Comprehensive Early Childhood Allergy Questionnaire
Will be used to evaluate allergy exposures and risk across the study period. This is a checklist of various common allergies that parents report the child having or not having each allergy.
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion30 Dec 2030 (estimated)
- Study completion30 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839156
- Sponsor's protocol ID
- STUDY00024490
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To comply with the rigor and reproducibility goals of the scientific community, we will make data available when required for publication in peer-reviewed scholarly journals. Any data shared for publication will be shared in repositories such as those managed by the U.S. government (e.g. dbGAP for microbiome sequence files and associated phenotype metadata) or Arizona State University. Data will be shared with the sponsor and made available for secondary data analyses upon reasonable investigator request. Further study protocols will be made available upon request to the PI and analytical code and statistical analyses will be shared through GitHub.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beyond the Bottle: Investigating the Differential Biological Effects of Cow's Milk and Oat Milk on Toddler Development
- ClinicalTrials.gov ID
- NCT07839156
- Acronym / sponsor ID
- STUDY00024490
- Conditions
- Gut Microbiome, Neurocognitive Correlates of Eating Habits, Infants and Young Children, Sleep
- Keywords
- milk, oatmilk, toddlers, growth, development, gut microbiome, neurocognitive, brain health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 30 Dec 2030 (estimated)
- Study completion
- 30 Jan 2031 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 12-month, 2-arm randomized controlled trial (n=150) examining whether toddlers randomized at 12 months of age to 1.5 cup-equivalents/day of cow's milk-based dairy versus oat milk-based dairy, and followed to 24 months, have better growth, sleep, neurocognitive, and gut microbiome outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cow's Milk | Experimental | Other: Daily cow's milk productsToddlers in the cow's milk group will receive 1.5 cup equivalents per day of cow-based dairy (1 cup of fluid milk + ½ cup equivalent of cheese (0.75 oz.) or yogurt (1/2 cup)). |
| Oat Milk | Active comparator | Other: Daily Oat Milk ExposureToddlers in the oat milk group will receive 1.5 cup equivalents per day of oat milk (1 cup fluid oat milk) + ½ cup equivalent of oat-based cheese (0.75 oz.) or yogurt (1/2 cup)). |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children born to mothers 18 years and older while pregnant
- Parents speak English and/or Spanish
- At least one caregiver in the home must have at least an 8th-grade education level
- Children still being breastfed into toddlerhood will be eligible to participate. Breastfeeding frequency and duration will be tracked in this case for statistical model adjustment.
Key exclusion criteria (10 listed)
- Children regularly taking probiotics and/or antibiotics (e.g., due to chronic ear infections)
- Children with known allergies to cow's milk or oat products
- Children introduced to fluid cow's or oat milk prior to 12 months of age however, yogurt and cheese made from cow's or oat milk will be acceptable and will be quantified for model adjustment during statistical analyses
- Children born with growth, chromosomal, or genetic abnormality, developmental and cognitive impairments, or severe comorbidity that could impact growth and development
- Children born with congenital abnormalities or developmental delays
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily cow's milk productsToddlers in the cow's milk group will receive 1.5 cup equivalents per day of cow-based dairy (1 cup of fluid milk + ½ cup equivalent of cheese (0.75 oz.) or yogurt (1/2 cup)). | Other | Cow's Milk |
| Daily Oat Milk ExposureToddlers in the oat milk group will receive 1.5 cup equivalents per day of oat milk (1 cup of fluid milk + ½ cup equivalent of cheese (0.75 oz.) or yogurt (1/2 cup)). | Other | Oat Milk |
Primary outcome
Gut Microbiome Diversity
Time frame: At enrollment to the end of treatment at 12 months
Microbial DNA extracted from toddler stool samples will undergo shotgun metagenomic sequencing to identify the unique species present in the gut microbial community and evaluate the richness and abundance of microbes present in the stool.
Toddler length
Time frame: From enrollment to the end of treatment at 12 months
Toddler length will be assessed with a pediatric length board and reported in centimeters.
Toddler weight
Time frame: From enrollment to the end of treatment at 12 months
Infant weight will be assessed with a calibrated scale and reported in grams.
Vineland Adaptive Behavior Scale (Vinland-3)
Time frame: From enrollment to the end of treatment at 12 months
A questionnaire completed by the parent/caregiver that is normed for ages from birth through 90 years. The tool assesses adaptive behaviors (things people do to function in everyday life) in three domains: communication, daily living skills, and socialization.
McArthur Bates Communicative Development Inventories III (MBCDI-III)
Time frame: From enrollment to the end of treatment at 12 months
A widely used checklist completed by parents to assess children's early communication skills such as comprehension and use of gestures and words.
Mullen Scales of Early Learning
Time frame: From enrollment to the end of treatment at 12 months
Study staff will administer a structured 15-minute play session with the infant to objectively assess motor, visual, and early language skills.
Brief Infant Sleep Questionnaire - Extended
Time frame: From enrollment to the end of treatment at 12 months
Sleep location, duration, quality, and interactions; validated for infants and toddlers through age 3 years; REDCap online. Scores range from 0-100 with higher scores representing healthier, more consolidated sleep patterns (e.g., shorter time to fall asleep, fewer and shorter night wakings).
Sleep-Wake Patterns measured by actigraphy (time awake and asleep)
Time frame: From enrollment to the end of treatment at 12 months
Actigraphy is a standard, valid, noninvasive measure for assessing sleep and circadian rhythm patterns across the life course. For infants and young children (e.g., toddlers), the actigraph is a small watch-like device that will be worn around the left ankle to record body motion (activity counts). The child will wear the devices for 7 continuous days and nights after all in-home visits. Constant assessment is necessary to capture the full development of sleep-wake patterns and circadian rhythmicity across toddlerhood. Home visits will be scheduled to avoid current illnesses or well-visits to avoid vaccination effects on sleep patterns. Primary sleep variables will be averaged across the recording period. Data will be reported in minutes of time that the child is awake or asleep.
Parent-Reported Sleep-Wake Patterns (time awake and asleep, and number of naps and perceived quality of sleep episodes)
Time frame: From enrollment to the end of treatment at 12 months
During actigraphy data collection, the parent/guardian will complete sleep diaries on the sleep of their toddler. Diaries will be used to identify artifacts that might affect motion (externally induced motion e.g. car seat, swing, or constricted motion e.g. swaddling), and to define sleep periods from actigraphy outputs for children prior to analysis with the sleep-wake algorithms. Primary sleep diary variables will be (1) bed/nap clock times attempted to sleep, (2) bed/nap clock times of sleep bout awakenings, and (3) time in bed or interval between attempted bed and wake times.
Home Observation for Measurement of the Environment Inventory (quality and extent of stimulation, support, and learning resources in the home)
Time frame: From enrollment to the end of treatment at 12 months
Research personnel will objectively evaluate the caring environment in which a child is raised and parent-child interaction using this validated assessment. The inventory qualitatively assesses the quality and extent of stimulation, support, and learning resources available in a child's home environment.
5 secondary outcomes
Infant 24-hour Diet Records
Time frame: From enrollment to the end of treatment at 12 months
Food intake photos showing the infant consuming intervention foods (compliance measure)
Time frame: From enrollment to the end of treatment at 12 months
Centers for Disease Control Infant Feeding Questionnaire to assess feeding practices in toddlerhood
Time frame: From enrollment to the end of treatment at 12 months
Food Security Screener
Time frame: From enrollment to the end of treatment at 12 months
Comprehensive Early Childhood Allergy Questionnaire
Time frame: From enrollment to the end of treatment at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Yes. To comply with the rigor and reproducibility goals of the scientific community, we will make data available when required for publication in peer-reviewed scholarly journals. Any data shared for publication will be shared in repositories such as those managed by the U.S. government (e.g. dbGAP for microbiome sequence files and associated phenotype metadata) or Arizona State University. Data will be shared with the sponsor and made available for secondary data analyses upon reasonable investigator request. Further study protocols will be made available upon request to the PI and analytical code and statistical analyses will be shared through GitHub.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily cow's milk products and Daily Oat Milk Exposure in people with Gut Microbiome and Neurocognitive Correlates of Eating Habits, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corrie M Whisner, PhD (602-496-3348, cwhisner@asu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut Microbiome Diversity (time frame: At enrollment to the end of treatment at 12 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.